Clinical trialNCT03239470TerminatedPhase 1Interventional

Polyclonal Regulatory T Cells (PolyTregs) for Pemphigus

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment5Pemphigus FoliaceusPemphigus Vulgaris

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

T cells, a type of white blood cell called a lymphocyte, play an important role in the immune system. One subtype, the regulatory T cell (Treg) helps to regulate the immune system and may provide protection against the development of autoimmune disease. The hope is that these naturally occurring Treg cells can be utilized for the treatment of autoimmune disease and potentially replace the use of chronic immunosuppressive therapies that are associated with multiple side effects. There has been a small study showing safe administration of Tregs with decreased disease activity in patients with insulin-dependent diabetes. Tregs are being studied in lupus, cancer and organ transplantation. This phase I trial will be conducted as an open-label, dose-escalation, multicenter trial in adult participants with active pemphigus.The purpose of this study is to test the safety and effect of Treg therapy in participants who have skin (cutaneous) involvement due to pemphigus.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Anna Haemel, MD
University of California San Francisco School of Medicine: Department of Dermatology
Study Chair
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David Wofsy, M.D.
University of California San Francisco School of Medicine: Lupus Clinic and Rheumatology Clinical Research Center
Study ChairKOL profile →
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Haley Naik, MD,MHSc
University of California San Francisco School of Medicine: Department of Dermatology
Study Chair
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Jeffrey Bluestone, Ph.D.
UCSF School of Medicine: UCSF Diabetes Clinic
Study Chair
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Michael Rosenblum, MD, Ph.D.
University of California San Francisco School of Medicine: Department of Dermatology
Study Chair
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

4 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of California San Francisco School of Medicine: Department of Dermatology
San Francisco, California, United States
University of Iowa Health Care: Department of Dermatology
Iowa City, Iowa, United States
Duke University Medical Center: Department of Dermatology
Durham, North Carolina, United States
University of Texas Southwestern Medical Center: Department of Dermatology
Dallas, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Cohort 1: 1.0 x 10^8 PolyTregsCohort 2: 2.5x10^8 PolyTregs

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 10 Oct 2017
Primary completion: 10 Dec 2020
Completion: 9 Jan 2023
Last update posted: 15 Feb 2024
Registered enrollment: 5
Registry id: NCT03239470

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.